Dagan 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

DAGAN 5mg orodispersible tablets EFG

Zolpidem tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What DAGAN is and what it is used for
2. What you need to know before taking DAGAN
3. How to take DAGAN
4. Possible side effects
5. How to store DAGAN
6. Contents of the pack and other information

1. What DAGAN is and what it is used for

Zolpidem tartrate is the active substance in DAGAN. It belongs to a group of medicines called hypnotics. It works in the brain to help you sleep.

DAGAN is used to treat short-term sleep disorders in adults that are causing severe anxiety or affecting your daily life. These sleep disorders in adults include, among others:

• Difficulty falling asleep
• Waking up during the night
• Waking up too early

Your doctor will, whenever possible, identify your sleep problem and the factors causing it before prescribing this medicine. If your sleep problems do not stop after 7 to 14 days of treatment, this may indicate an underlying disorder, and your doctor will periodically reassess you.

DAGAN is not intended to be used every day for long periods of time (treatment should be as short as possible and not exceed 4 weeks). If you are unsure, consult your doctor.

2. What you need to know before taking DAGAN

Do not take DAGAN:

• if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include, among others: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if your lungs do not function properly (respiratory failure).
• if you have severe liver problems.
• if you suffer from a condition in which you stop breathing for short periods during sleep (sleep apnea).
• if you have a disorder causing severe muscle weakness (myasthenia gravis).
• if your doctor has informed you that you have a mental illness (psychosis).
• if you are under 18 years of age.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking zolpidem.

Warnings and precautions

Consult your doctor or pharmacist before taking DAGAN if:

• You have a history of alcohol or drug abuse.
• You suffer from liver problems.
• You suffer from depression or have had other mental illnesses in the past.
• You have recently taken zolpidem or similar medicines for more than four weeks.
• You suffer from kidney problems.
• You suffer from respiratory problems.
• You are elderly or frail.

Zolpidem may cause drowsiness and reduce your level of alertness. This could lead to falls and sometimes serious injuries.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before taking zolpidem.

Duration of treatment

• Once you start taking DAGAN, you should know that it is intended for short-term use only.
• You should take zolpidem for a short period, not exceeding 4 weeks.
• You should always visit your doctor as scheduled to reassess your condition.

Next-day psychomotor impairment (see also Driving and use of machines)

The risk of next-day psychomotor impairment, including impaired driving ability, increases the day after taking zolpidem if:

• You take this medicine less than 8 hours before performing activities requiring alertness.
• You take a higher dose than recommended.
• You take zolpidem together with another central nervous system depressant or another medicine that increases zolpidem levels in your blood, combined with alcohol or illegal substances.

Take a single dose immediately before going to bed at night. Do not take another dose during the same night.

Other medicines and DAGAN

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because zolpidem may affect how other medicines work. Likewise, some medicines may affect how zolpidem works.

Zolpidem may enhance the effect of muscle relaxants.

Rifampicin, a medicine used to treat tuberculosis, may reduce the effect of zolpidem.

Tell your doctor if you are taking any of the following medicines:

DAGAN may increase the effect of the following medicines:

If you take DAGAN with the following medicines, it may increase drowsiness and next-day psychomotor impairment, including impaired driving ability:

• Medicines for certain mental disorders (antipsychotics)
• Medicines for sleep problems (hypnotics)
• Medicines to relieve or reduce anxiety
• Medicines for depression
• Medicines for moderate to severe pain (narcotic analgesics)
• Medicines for epilepsy
• Medicines used for anesthesia
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that may cause drowsiness (sedating antihistamines)

If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

If you take zolpidem with narcotic analgesics, you may feel euphoric and your dependence may increase.

Taking zolpidem with fluvoxamine is not recommended.

The following medicines increase the likelihood of side effects when taken with DAGAN. To reduce this risk, your doctor may decide to lower your zolpidem dose:

• Some antibiotics such as ciprofloxacin (use not recommended)
• Some medicines used to treat fungal infections, such as ketoconazole or itraconazole

Taking DAGAN with food and drinks

• Do not drink alcohol while taking zolpidem. Alcohol may enhance the effects of zolpidem and cause you to sleep so deeply that you may not breathe properly or have difficulty waking up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Taking DAGAN during pregnancy may be harmful to your baby.

Zolpidem should not be administered during pregnancy, especially during the first three months. If, for urgent medical reasons, you take zolpidem during the last months of pregnancy or during childbirth, your baby may experience low body temperature, muscle spasms, breathing difficulties, and withdrawal symptoms after birth due to physical dependence.

You should not breastfeed while taking zolpidem, as this medicine is excreted in small amounts in breast milk.

Seek advice from your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

Driving and use of machines

DAGAN has a significant effect on the ability to drive and operate machinery, such as "driving while drowsy." The day after taking zolpidem (as with other hypnotics), you should be aware that you may experience the following:

• You may feel sluggish, drowsy, dizzy, or confused
• You may take longer than usual to make decisions
• You may suffer blurred or double vision
• Your level of alertness may be reduced

To reduce the aforementioned effects, a minimum interval of 8 hours between taking zolpidem and driving, operating machinery, or performing work at heights is recommended.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the effects mentioned above.

DAGAN contains:

• Lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
• Aspartame (E951): This medicine contains 2.5 mg of aspartame per tablet. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• Ammonium sulfite caramel (E150d): This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sulfites.

3. How to take DAGAN

Follow exactly the instructions for using DAGAN as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Taking this medicine

• Take this medicine by mouth.
• Place the tablet on the tongue and allow it to dissolve completely without chewing. Swallow the resulting suspension with saliva. You may then drink water, but this is not required.
• The recommended dose is 10 mg of DAGAN every 24 hours.
• A lower dose may be prescribed for some patients.
• Zolpidem should be taken as a single dose immediately before going to bed at night.
• Ensure that you allow a minimum interval of 8 hours between taking the medicine and performing activities requiring alertness.
• Do not take more than 10 mg every 24 hours.
• The usual duration of treatment is 2 to 4 weeks. The maximum treatment period, including the gradual dose reduction process, is four weeks.

Adults

The recommended dose is two 5 mg tablets or one 10 mg tablet (10 mg) taken immediately before bedtime. The maximum dose of 10 mg must not be exceeded.

Elderly or debilitated patients (over 65 years of age)

The recommended dose is one 5 mg tablet taken immediately before bedtime. This recommended dose must not be exceeded.

Patients with liver problems

The initial dose is one 5 mg tablet taken immediately before bedtime. Your doctor will decide whether the dose should be increased to two 5 mg tablets or one 10 mg tablet, if considered safe.

Do not take zolpidem if you have severe liver disorders.

Use in children and adolescents

DAGAN must not be used in children under 18 years of age.

If you take more DAGAN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.

Take the medicine packaging with you so the doctor knows what you have taken. Taking too much zolpidem is very dangerous. The following effects may occur:

• Drowsiness, confusion, hypotension, breathing difficulties, deep sleep, and possible progression to life-threatening coma.

If you forget to take DAGAN

DAGAN should only be taken at bedtime. If you forget to take your dose at bedtime, do not take it at any other time, as this may cause daytime drowsiness, dizziness, and confusion.

Do not take a double dose to make up for a missed dose.

If you forget to take the dose immediately before going to bed but remember during the night, simply take the missed dose if you can still sleep for 7 to 8 hours uninterrupted.

If you stop taking DAGAN

Continue taking DAGAN until your doctor tells you to stop. Do not stop treatment with zolpidem suddenly, but inform your doctor if you wish to discontinue. Your doctor will need to gradually reduce your dose and discontinue the tablets over a period of time.

If you stop taking zolpidem suddenly, you may experience a return of sleep problems and what are known as "withdrawal symptoms." If this happens, you may notice the following effects:

Go immediately to your doctor if any of the following occur:

• Feeling anxious and tense, restless, irritable, or confused
• Headache
• Nightmares, seeing or hearing things that are not real (hallucinations)
• Increased sensitivity to light, noise, and touch
• Disturbance in perception of reality
• Feeling detached from your body or like a puppet
• Numbness and tingling in hands and feet
• Muscle pain
• Worsening of sleep disorders

In rare cases, seizures (convulsions) may also occur.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking DAGAN and tell your doctor or go immediately to a hospital if:

• You experience an allergic reaction. Signs of an allergic reaction include, among others: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue. These adverse effects are serious but their frequency is unknown (cannot be estimated from the available data). You need immediate medical attention.

Tell your doctor as soon as possible if any of the following adverse effects occur:

Frequent (affects less than 1 in 10 people)

• Memory problems while taking zolpidem (amnesia) and unusual behavior during this time, an effect more likely to occur a few hours after taking the medicine. After 7–8 hours of sleep following zolpidem intake, it is less likely to cause problems.
• Worsening of difficulty in sleeping after taking this medicine.
• Seeing or hearing things that are not real (hallucinations).

Uncommon (affects less than 1 in 100 people)

• Blurred vision or double vision.

Frequency not known (frequency cannot be estimated from the available data)

• Reduced awareness of your surroundings.
• Falls, especially in elderly people.

Sleep-driving and other unusual behaviors

There have been reports of individuals carrying out activities while asleep and not remembering them upon waking, after taking a sleeping medicine. These activities include sleep-driving, sleepwalking, or engaging in sexual activity. Alcohol and certain antidepressants or anti-anxiety medications may increase the likelihood of these serious effects occurring.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

Frequent (affects less than 1 in 10 people)

• Diarrhea
• Feeling dizzy (nausea) or vomiting
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or restless
• Having nightmares
• Feeling detached from reality and being unable to think or judge clearly (psychosis)
• Feeling dizzy
• Feeling drowsy or sleepy
• Back pain

Uncommon (affects less than 1 in 100 people)

• Feeling confused or irritable

• Unusual skin sensations such as numbness, tingling, prickling, or burning of the skin (paresthesia)

• Tremor

• Blurred vision

• Changes in appetite or appetite-related behavior

• Muscle aches

• Muscle spasms

Very rare (affects less than 1 in 10,000 people)

• Any visual disturbance, particularly loss of vision

Frequency not known: (frequency cannot be estimated from the available data)

• Itching or skin rash
• Excessive sweating
• Slowed breathing (respiratory depression)
• Muscle weakness
• Feeling restless, aggressive, angry, or displaying unusual behavior
• Depression
• Exaggerated sense of well-being/confidence (euphoria)
• Believing things that are not real (delusions)
• Changes in sexual desire (libido)
• Changes in the levels of liver enzymes (detected in blood test results)
• Change in skin or eye whites color, abdominal (stomach) pain or bloating sensation, intense itching, pale or bloody stools, extreme weakness, nausea, or loss of appetite. These signs may be due to liver infection or injury.
• A condition in which bile flow from the liver is blocked (cholestasis). Signs include jaundice (yellowing of the skin), rash or fever, and darkening of urine.
• Difficulty concentrating
• Speech problems
• Changes in the way of walking
• Zolpidem has less effect than usual
• Becoming dependent on zolpidem

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of DAGAN

Keep this medicine out of the sight and reach of children.

This medicine does not require special temperature conditions for storage. Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of DAGAN 5 mg orodispersible tablets

• The active substance is zolpidem tartrate.

Each DAGAN tablet contains 5 mg of zolpidem tartrate.

• The other components (excipients) are potassium polyacrylate, mannitol, monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, aspartame (E951), blackcurrant flavouring (flavouring substances, corn maltodextrin (derived from corn starch), glyceryl triacetate, triethyl citrate, ammonium sulphite caramel (E150d)).

Appearance of the product and contents of the container

The 5 mg orodispersible tablets are:

white to off-white, round, flat, bevelled tablets, marked with "5" on one side and smooth on the other side, with a diameter of 7.0 mm ± 0.3 mm, thickness of 3.1 mm ± 0.3 mm, and a blackberry odour.

The orodispersible tablets are packaged in aluminium/aluminium blisters.

Blister foil components – Base foil: PVC-OPA-Aluminium-PVC; Top foil: Aluminium-PVC.

DAGAN 5 mg is available in packs of 14, 28, 30 and 56 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Manufacturer:

LAMP SAN PROSPERO S.P.A

Via della Pace, 25/A

CP 41030 San Prospero

Modena

Italy

or

INPHARMASCI

ZI No. 2 de Prouvy – Rouvignies

1 rue de Nungesser

59121 Prouvy

France

Date of the most recent revision of this leaflet: May 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/